Application device for nasal splints

ABSTRACT

In accordance with invention an application device for nasal splints is created, comprising at least one hollow body for accommodating a nasal splint, and a plunger which can be moved within the hollow body, wherein one end face of the hollow body is open so that a nasal splint contained in the hollow body can be introduced through a movement of the plunger from the hollow body through the open end face into the nose of a patient.

The invention relates to an application device for nasal splints as wellas a nasal splint.

Nasal splints are used for the postoperative stabilisation and splintingof the nasal septum. Here, after an operation the nasal septum issplinted by way of two plastic plates (nasal splints) in order to assurestraight growing together of the nasal septum, a splint to provideepithelialisation of mucous membrane wounds and to prevent bloodeffusion. For this the splints are fixed to the nasal septum throughsutures or tamponades. A disadvantage of this is that too tight a suturecan lead to pressure necrosis, while too slack a suture does notadequately fix the nasal splints.

It is known to provide nasal splints with magnets so that two oppositenasal splints applied to the nasal septum attract each othermagnetically and become fixed to the nasal septum. Such nasal splintsare known from U.S. Pat. No. 4,402,314. Here too there is the problemthat too strong magnetic forces can lead to necrosis, where too week amagnetic force may not be sufficient to adequately fix the nasal splintsin place.

Conventionally such nasal splints are introduced into the nostrils of apatient by means of tweezer-like applicators. In order to allowproblem-free introduction of the splints their size is orientated to thesize of the patient's nostrils. However, this can result in the surfacearea of the nasal splint being too small in relation to the surface areaof the nasal septum.

The objective is to eliminate or reduce this problem.

This task is solved by the invention set out in claim 1. Advantageousembodiments can be found in the sub-claims. A further aspect of thepresent invention is set out in the sub-claims.

In accordance with the invention an application device for nasal splintsis created, comprising at least one hollow body for accommodating anasal splint and a plunger which can be moved in the hollow body,wherein one end face of the hollow body is open so that through amovement of the plunger a nasal splint contained in the hollow body canbe introduced from the hollow body through the open end face into thenose of a patient.

By means of the application device in accordance with the inventionnasal splints can be simply introduced into a patient's nose. For this anasal splint is first of all accommodated in the hollow body of theapplication device in a folded together or rolled up state. Theapplication device is then inserted with the end opening into the noseof the patient. Thereafter the plunger in the hollow body is moved inthe direction of the patient so that the nasal splint is pushed out bythe plunger. Hereupon the nasal splint unfolds and attaches itself tothe nasal septum of the patient.

By means of the application device in accordance with the inventionnasal splints with a surface area larger than conventional nasal splintscan be inserted into the nose of a patient. The nasal splints can beheld in the application device in a rolled-up or folded together stateand introduced into the nose. As the nasal splints are not yet unfoldedor unrolled during the introduction process their size is not restrictedby the size of the nostril. In all events the introduction process ismore pleasant for the patient and the risk of injury to the nasalopening is reduced.

Advantageously this not only provides the possibility of introducinglarger nasal splint into the nose of a patient. Rather, it also allowsnasal splints of a sufficient standard size to be used, whereby thestandard size can be orientated to the size of the nasal septum of anaverage patient, irrespective of the size of the nostrils.

A further advantage of the present invention consists in the fact thatthe application device is simple to manufacture. In principle it is alsopossible to produce the application device through providing aconventional plastic syringe, the cylindrical hollow body of which iscut or sawn off, so that the end face on the side of the syringe facingthe patient is open. Through this opening a folded together or rolled upnasal splint can be inserted into the hollow body and then introducedinto the nose of a patient. In other words, the hollow body of theapplication device corresponds to the main body of a syringe, butwithout the tapering projection with the needle.

In an advantageous embodiment the at least one hollow body has anon-rounded cross-section, more particularly a cross-section with anessentially straight first side and an opposite rounded second side.Preferably the cross-section of the hollow body is adapted to thecross-section of the nostril of an average patient whereby theintroduction of the application device into the patient's nose isfacilitated.

In accordance with one embodiment of the invention the end face of theat least one hollow body facing is angled with regard to thelongitudinal axis of the hollow body. As a result, the hollow body has agreater length on one side than on the opposite side. To insert a nasalsplint the longer side of the hollow body is inserted past the nasalcolumella into the nose of a patient. Due to the angle the hollow bodydoes not have to be fully introduced into the nose.

In a preferred embodiment the application device has two hollow bodies,more particularly arranged in parallel to each other. The two hollowbodies can be identical. By means of such an application device twonasal splints can be introduced into both nostrils of a patient at thesame time. This prevents the magnetic force of one film that is alreadypositioned in the patient developing an undesirable effect on the filmthat is still to be introduced.

In one embodiment the two hollow bodies are connected to each other,wherein between the two hollow bodies an intermediate space is providedin which the columella of a patient comes to lie during an insertionprocedure. An application device designed in this way can thus beintroduced sufficiently far into the patient's nostrils without thecolumella of the patient being in the way or being stressed too much.

In one embodiment the application device comprises an operating element,more particularly a thumb rest, which is connected to both plungers andwith which the plungers of both hollow bodies can be moved at the sametime in both hollow bodies in one operation. In the case of thisembodiment two plungers can thus be moved simply by pressing theoperating element.

In accordance with the invention a nasal splint is also created whichcomprises a basic body made of an elastic material, wherein a nasalsplint can be arranged folded together or rolled up in the hollow bodyof the application device. A nasal splint of this type can be of anysize in relation to the nasal septum. In other words, the size of thenasal splint can be orientated to the size of the nasal septum and isnot, for example, restricted by the size of a patient's nostrils.

Preferably the nasal splint has a surface area of between 1,620 and1,750 mm², more particularly between 1,670 and 1,700 mm². This size issuitable as a standard size for various patients with differently sizednasal septa. The length of the nasal splints can be 64-70 mm, moreparticularly around 67. The height can be between 15 and 34 mm, wherebythe nasal split has a smaller height in a frontal area than in a reararea. More particularly, the height in a frontal area can beapproximately 18 mm and in a rear area approximately 31 mm.

In one embodiment the nasal splint has several magnets, moreparticularly NdFeB magnets, wherein the magnets are designed andarranged in such a way that the pressure of the nasal splints on thenasal septum of a patient is between 1.9 kPA and 5.6 kPA if anothersplint of the same type is arranged on the other side of the nasalseptum. These values have also turned out to be suitable standard valuesfor different patients with nasal septa of varying sizes. Decisive isthe sum of the exerted forces in relation to the surface area on whichthey are acting. It has also been established that these values are thesolution to the problem set out in the introduction and also result inthe nasal splints being securely fixed to the nasal septum withoutcausing local blood circulation problems or pressure necrosis.

It has been established that NdFeB magnets, for example magnets based onrare earth metals, have a high retaining force in relation to theirsize.

In one embodiment of the invention the basic body of the nasal splint ismade of silicone, more particularly a silicone film with a siliconehardness of 30-70 Shore, preferably around 50 Shore. The basic body canthus be adapted to the shape of the nasal septum on which the nasalsplint is to be applied. In the embodiment the nasal splint issufficiently flexible to be introduced in a rolled-up state into thenose of a patient with the application device in accordance with theinvention. However, at the same time the nasal splint is hard enough todistribute the pressure produced by the magnets evenly over the surfaceof the nasal splint to the mucous membrane and the nasal septum.

In an advantageous embodiment of the nasal splint the thickness of thebasic body is thinner in marginal area than in the middle of the basicbody. This prevents shear forces developing on possibly postoperativelythickened mucous membrane which could lead to injuries.

In one embodiment of the nasal splint it is produced by means ofinjection moulding. In contrast to production by cutting to size,production by injection moulding has the advantage that no undesirableedges or burring occur at the margins. Additionally, when produced byinjection moulding the nasal splint can be made thinner in the marginalarea.

More particularly, the nasal splint can be made of a film of differentmaterials. Suitable, for example, are silicone and polyethylene, whichboth have a very smooth surface. The magnets can be attached to the filmwith acrylate adhesives.

There are various possibilities of securing the magnets on the film. Inone embodiment the magnets are adhered in recesses of the carrier film.In another embodiment the magnets are covered with thin second film. Ina further embodiment the magnets are baked into the film while the filmis being produced.

The contour of the nasal splint is adapted to the contour of thepatient's nasal septum. More particularly, the contour of the nasalsplint is adapted in sections to the corresponding regions of the nasalseptum so that clear allocation of the sections of the nasal splint tothe corresponding areas of the nasal septum is possible.

In accordance with the invention a nasal splint device is also createdcomprising a nasal splint with a basic body made of elastic material anda retaining device for the detachable holding of the nasal splint in arolled-up or folded together state. Thereby, in comparison with nasalsplints in accordance with the prior art which have to be inserted intothe nose in the conventional manner, the nasal splint in accordance withthe invention can have a large surface area.

The retaining device can be formed by one or more loosenable threads ora retaining film which can be loosened or detached or is made of awater-soluble material, or retaining film with a perforation. Such aretaining device favours gentle introduction of the nasal splint intothe patient's nose.

In an alternative embodiment the retaining device is formed by anelastic tube in which the nasal splint is arranged, wherein the nasalsplint can be introduced from the elastic tube into the patient's noseby means, for example, of a plunger or by compressed air. A retainingdevice of his type is inexpensive to produce and simple to use.

In one embodiment complementary projections and recesses are arranged onopposite edges of the nasal splint which in the rolled-up state of thenasal splint engage which each other and can be fixed to each other bythe retaining device. The retaining device can be formed by a thread orwire which is arranged within a hole in the projections. This embodimentallows simple loosening of the retaining device in order to unroll thenasal splint.

In accordance with the invention a device set is also created comprisingan application device with a nasal splint accommodated in a rolled up orfolded together manner in the hollow body. By means of such device theaforementioned advantages can be implemented.

In accordance with the invention a method of producing a nasal splint isalso created wherein the nasal splint has a basic body with at least onerecess, each for receiving at least one magnet, the method comprisingthe arrangement of a non-ferromagnetic body with at least one auxiliarymagnet on the basic body in such a way that the auxiliary magnet exertsa magnetic attraction force on a magnet accommodated or to beaccommodated in the recess; and the application, more particularly theadhesion, of a cover film on the basic body over the magnet in therecess. By means of this method it can be prevented that the holdingmagnets loosen from the basic body during the production of the nasalsplints, more particularly because of the magnetic forces acting betweenthe holding magnets.

In an expedient embodiment the at least one auxiliary magnet is anelectromagnet so that the magnetic force can be activated during theproduction process and then deactivated again.

Examples of embodiments of the invention will be described in moredetail below by way of the drawings. Schematically:

FIG. 1 shows an application device for nasal splints in accordance withone embodiment of the present invention;

FIG. 2 shows a perspective view of the application device in FIG. 1;

FIG. 3 shows a nasal splint in accordance with one embodiment of theinvention;

FIG. 4 shows a nasal splint in accordance with a further embodiment ofthe invention;

FIG. 5 shows a nasal splint in accordance with another embodiment of theinvention;

FIG. 6 shows the nasal splint in FIG. 5 in the rolled-up state;

FIGS. 7 to 9 show a detailed view of the nasal splint in FIG. 5;

FIGS. 10 and 11 show stages in a method of producing a nasal splint 5 inaccordance with one embodiment of the invention; and

FIGS. 12 and 13 show a nasal splint in a further embodiment of theinvention.

FIG. 1 shows an application device 1 for nasal splints in accordancewith one embodiment of the present invention. The application devicecomprise a first hollow body 2A and a second hollow body 2B which areessentially arranged in parallel to one another. One end face 3 of thehollow body 2A, 2B facing the patient is open (opening 4) so that nasalsplints 5 accommodated in the hollow bodies can be introduced into thenose of a patient through the opening 4. The opening 4 essentiallyextends over the entire end face 3 of the hollow bodies 2A, 2B.

At the ends facing away from the patient the two hollow bodies 2A, 2Bare connected to each other by means of a strip 6. The two hollow bodies2A, 2B are also at a distance from each other so that between then anintermediate space 7 with an end open towards the patient is formed. Thewidth of the intermediate space, i.e. the distance between the hollowbodies 2A, 2B essentially corresponds to the width of the columella ofan average patient. For example, the distance can be between 2 and 10mm, more particularly approximately 5-7 mm.

Arranged in each of the hollow bodies 2A, 2B is a stamp or plunger 8Aand 8B respectively that is movable in the longitudinal direction. InFIG. 1 the plungers 8A, 8B are retracted so that there is spaceavailable in the hollow bodies 2A, 2B for accommodating the nasalsplints 5.

At the end facing away from the patient the plungers 8A, 8B areconnected to each other via a strip through which a joint thumb rest 9is formed. Thus, through pressing the thumb rest 9 the pistons 8A, 8Bcan be jointly moved in the direction of the end of the applicationdevice 1 facing the patient.

The face end 3 of the hollow bodies 2A, 2B runs obliquely to thelongitudinal axis of the hollowing bodies 2A, 2B. The angle between theend face 3 and the longitudinal axis of the hollow bodies 2A, 2B is inthe range between 30° and 60°, preferably around 45°. As a result ofthis the hollow bodies each have a longer outer side 10 and a shorterouter side 11, wherein the longer outer sides 10 are on the inside, i.e.they form the intermediate space 7 between the hollow bodies 2A, 2B.

Arranged in each of the hollow bodies 2A, 2B is a rolled-up or foldedtogether nasal splint 5. In use, the application device 1 is used tointroduce the splints 5 from the hollow bodies 2A, 2B into the nose of apatient. For this the hollow bodies 2A, 2B are initially partiallyinserted into the patient's nostrils, whereby the columella of thepatient comes to rest in the intermediate space 7 between hollow bodies2A, 2B. By pressing on the thumb rest 9 the plungers 8A, 8B are thenmoved in the direction of the end of the application device 1 facing thepatient so that the nasal splints 5 are pushed by the pistons 8A, 8Bthrough the openings 4 and into the nostrils. During this the hithertorolled-up nasal splint 5 can unroll or unfold and apply themselves tothe patient's nasal septum. As will be explained below, the nasalsplints 5 are fixed by magnetic force to the patient's nasal septum.

FIG. 2 schematically shows a perspective view of the application device1 in FIG. 1. It can be seen that the hollow bodies 2A, 2B each have anunrounded cross-section. More particularly, the cross-section of thehollow bodies 2A, 2B resembles the cross-section of the nostrils of anaverage patient. In cross-section the hollow bodies 2A, 2B each have astraight side 12 and a rounded side 13, wherein the straight sides 12are opposite each other and define the intermediate space 7. Essentiallythe cross-section of each of the hollow bodies 2A, 2B corresponds tothat of a wing, wherein the straight sides 12 correspond to theunderside and the rounded sides 15 to the upper sides of the wing.

The arrows schematically show the direction in which the nasal splints 5are ejected from the hollow bodies 2A and 2B when operating the plungers8A, 8B and introduced into the nose of a patient.

In an alternative embodiment, which is not shown, the hollow bodies 2A,2B are cylindrical in shape with a round cross-section.

The hollow bodies 2A, 2B and the plungers 8A, 8B consist of abiocompatible material.

FIG. 3 shows a nasal splint 5 in accordance with an embodiment of thepresent invention for use with the application device 1 in FIGS. 1 and2. The nasal splint 5 has a basic body 14 made of elastic silicone. Moreparticularly, the basic body is made of a silicone film with a siliconehardness of around 50 Shore. Through this the basic body 14 issufficiently flexible in order to be arranged in the hollow bodies 2A,2B of the application device in a rolled-up or folded together state, asshown schematically in FIGS. 1 and 2.

The thickness of the basic body 14 decreases in the direction towardsthe edge so that the contact pressure and shear forces in the marginalarea the nasal splint are smaller which protects the nasal mucousmembrane of the patient. Furthermore, the basic body 14 can be producedby means of injection moulding as a result of which undesirable edges orburring on the margin of the basic body 14 can be avoided.

The outer contour of the nasal splint 5 is adapted to the shape of thenasal septum of an average patient. Because of the possibility ofintroducing the nasal splint 5 in a rolled up state 1 into the nose of apatient by means of the application device 1 in accordance with theinvention, the nasal splint 5 has a larger surface area in relation toconventional nasal splints. A standard surface area of 1685 mm² hasproven to be particularly advantageous. A nasal splint 5 designed inthis way can be used as standard for patients with differently sizednasal septa. There is therefore no need to individually adapt thesurface area of the nasal splint depending on the patient.

In the shown embodiment the nasal splint 5 has six circular magnets 15which are evenly distributed over the surface area of the basic body 14.By means of the magnets 15 a magnetic force is exerted on the nasalsplint 5 of the same type arranged on the opposite side of the nasalseptum. The magnets 15 are of such a type and arranged that the contactpressure on the nasal septum is between 1.9 kPa and 5.6 kPa.

FIG. 4 shows the nasal splint 5 in an alternative embodiment. The nasalsplint 5 in accordance with FIG. 4 differs from the nasal splint 5 inaccordance with FIG. 3 more particularly in terms of the design andnumber of magnets. In the embodiment shown in FIG. 4 the nasal splint 5has two essentially rectangular magnets 16 arranged in parallel to eachother. The magnets 16 are otherwise designed so that essentially thesame contact pressure is generated as through magnetics in FIG. 3. Themagnetic force is determined by the material type and volumetric mass ofthe body. The aim of as even a contact pressure as possible cantherefore be achieved more easily through a larger number of smallermagnets then through a few large magnets. The magnetic film represents amaximum manifestation of this principle.

FIG. 5 shows the nasal splint 5 in a further alternative embodiment ofthe invention. In this embodiment on one longitudinal edge the nasalsplint 5 has projections 18 and adjacent recesses 19, as well as, on theopposite longitudinal edge complementary projections 18′ and recesses19′. When rolling up the nasal splint 5 the projections 18 engage in therecesses 19′ and the projections 18′ in the recesses 19 are shown by thearrows.

FIG. 6 shows the nasal splint 5 from FIG. 5 in the rolled-up state withopposing magnets 17, wherein in terms of the operating principle themagnets 17 correspond to the magnet 15 and 16 in FIGS. 3 and 4.

In the rolled-up state the projections 18, 18′ and recesses 19, 19′engage in each other and are fixed to each other by a thread or wire asshown in detail in FIGS. 7-9. The thread 20 is arranged within a hole 21in the projections 18, 18′ extending in parallel to the outer edge ofthe nasal splint 18, 18′.

After introducing the nasal splint 5 into the nostril of a patient, thethread can be pulled out of the hole 21 so that the fixation is loosenedand the nasal splint 5 can unroll.

FIGS. 10 and 11 show stages in a process of producing the nasal splint 5in accordance with one embodiment of the invention. According to this,in a basic body 22 for each magnet 12 a recess 23 shaped to correspondwith the magnet 17 is provided. After taking up the magnet 17 in therecess 23 a cover film 24 is adhered to the basic body 22, as a resultof which the magnet 17 is fixed in the recess 23.

In order to fix the magnet 17 in its position during the production ofthe nasal splint 5, a non-ferromagnetic body 25 is arranged under thebasic body 22. The outline of the body 25 corresponds to the basic body22. An auxiliary magnet 26 is provided in the body 25 arranged under therecess 23 and has the opposite polarity to the magnet 17. After adheringthe cover film 24 the magnet 25 can be removed again. Several suchauxiliary magnets 26 can be provided, corresponding to the number ofmagnets 17, wherein the auxiliary magnets 26 are each arranged flushwith the magnets 17.

FIGS. 12 and 13 show the nasal splint 5 in another alternativeembodiment. In this embodiment a retaining film 27 is provided whichholds the nasal splint 5 in the rolled up state. Along the connectionpoint of the opposite side edges of the nasal splint the retaining film27 has a perforation 28. By severing the retaining film 27 along theperforation 28 the nasal splint 5 can be unrolled.

In one embodiment the retaining film 27 is formed by the cover film 24(cf. FIGS. 10 and 11).

REFERENCE NUMBERS

-   1 Application device-   2A, 2B Hollow body-   3 Face end facing the patient-   4 Opening-   5 Nasal splint-   6 Strip-   7 Intermediate space-   8A, 8B Plunger-   9 Thumb rest-   10 Longer outer side-   11 Shorter outer side-   12 Straight side-   13 Round side-   14 Basic body-   15 Round magnets-   16 Rectangular magnets-   17 Magnets-   18, 18′ Projections-   19, 19′ Recesses-   20 Thread-   21 Hole-   22 Basic body-   23 Recess-   24 Cover film-   25 Non-ferromagnetic body-   26 Auxiliary magnet-   27 Retaining film-   28 Perforation

The invention claimed is:
 1. Application device operable for theapplication of nasal splints, comprising at least one nasal splint, atleast one hollow body for accommodating the at least one nasal splint,and a plunger which is movable inside the at least one hollow body,wherein one end face of the at least one hollow body is open so that theat least one nasal splint contained in the at least one hollow body canbe introduced from the at least one hollow body through the open endface into the nose of a patient by a movement of the plunger, whereinthe at least one hollow body has an at least in part unroundedcross-section.
 2. Application device according to claim 1 wherein theopen end face is a distal end face of the at least one hollow body whichextends obliquely with regard to a longitudinal axis of the at least onehollow body.
 3. Application device according to claim 1, wherein the atleast one hollow body comprises first and second hollow bodies, thefirst hollow body having the plunger movable therein, and the secondhollow body having a second plunger movable therein.
 4. Applicationdevice according to claim 3 wherein the first and second hollow bodiesare connected to one another and between the first and second hollowbodies an intermediate space is provided in which the columella of apatient can come to rest during an introduction procedure. 5.Application device according to claim 4, comprising a thumb rest (9)which is connected to both the plunger and the second plunger and withwhich the plunger and the second plunger can be moved simultaneouslywithin the first and second hollow bodies, respectively, with oneoperation.
 6. Application device according to claim 3 wherein the firstand second hollow bodies are arranged in parallel to one another. 7.Application device according to claim 1 wherein the at least one hollowbody has a cross-section with one generally straight side and anopposite, rounded, second side.
 8. Application device operable for theapplication of nasal splints, comprising at least one nasal splint, atleast one hollow body for accommodating the at least one nasal splint,and a plunger which is movable inside the at least one hollow body,wherein one end face of the at least one hollow body is open so that theat least one nasal splint contained in the at least one hollow body canbe introduced from the at least one hollow body through the open endface into the nose of a patient by a movement of the plunger, whereinthe open end face is a distal end face of the at least one hollow bodywhich extends obliquely with regard to a longitudinal axis of the atleast one hollow body.
 9. Application device operable for theapplication of nasal splints, comprising first and second nasal splints,first and second hollow bodies for accommodating the first and secondnasal splints, respectively, and first and second plungers which aremovable inside the first and second hollow bodies, respectively, whereina first end face of the first hollow body is open so that the firstnasal splint contained in the first hollow body can be introduced fromthe first hollow body through the first end face into the nose of apatient by a movement of the first plunger, and, wherein a second endface of the second hollow body is open so that the second nasal splintcontained in the second hollow body can be introduced from the secondhollow body through the second end face into the nose of a patient by amovement of the second plunger.
 10. Application device according toclaim 9 wherein the first and second hollow bodies are connected to oneanother and between the first and second hollow bodies an intermediatespace is provided in which the columella of a patient can come to restduring an introduction procedure.
 11. Application device according toclaim 10, comprising a thumb rest which is connected to both the firstplunger and the second plunger and with which the first plunger and thesecond plunger can be moved simultaneously within the first and secondhollow bodies, respectively, with one operation.
 12. Application deviceaccording to claim 9 wherein the first and second hollow bodies arearranged in parallel to one another.
 13. Application device operable forthe application of nasal splints, comprising at least one nasal splint,at least one hollow body for accommodating the at least one nasalsplint, and a plunger which is movable inside the at least one hollowbody, wherein one end face of the at least one hollow body is open sothat the at least one nasal splint contained in the at least one hollowbody can be introduced from the at least one hollow body through theopen end face into the nose of a patient by a movement of the plunger,wherein the at least one hollow body has a cross-section with onegenerally straight side and an opposite, rounded, second side.